Emgality demonstrated significant response rates in the reduction of mean monthly MHDs in any given month vs placebo1

Emgality response rates chart

ap<0.001 vs placebo.


Up to 62% of patients had a ≥50% reduction of monthly MHDs in any given month, on average (p<0.001)1

Up to 39% of patients achieved a ≥75% reduction of monthly MHDs in any given month, on average (p<0.001)1

Up to 1 in 7 patients (16%) were 100% migraine headache-free in any given month, on average (p<0.001)1


See study design for EVOLVE-1 and EVOLVE-2

100% reduction of monthly MHDs in at least 1, 2, or 3 months12

Emgality response rates

Post-hoc analyses of EVOLVE-1 and EVOLVE-2 pooled data. Results reported are simple calculations of percentages. As these analyses are post hoc, no conclusions of statistical or clinical significance can be drawn.

See study design for EVOLVE-1 and EVOLVE-2

≥50% reduction of monthly MHDs in preventive naïve and prior preventive failures13-15

Emgality test response rate

Post-hoc analysis of EVOLVE-1 and EVOLVE-2 pooled data. The studies were not adequately powered nor error-controlled for subgroup analyses. Treatment differences observed in these subgroups cannot be regarded as statistically significant. Patients were excluded from the studies if they had previously failed to have an efficacy response to ≥3 classes of migraine preventive treatments with Level A or B efficacy according to the American Academy of Neurology’s Evidence-based Guideline Update: Pharmacologic Treatment for Episodic Migraine Prevention in Adults as well as botulinum toxin A or B. Assignment to the subgroup of patients who were naïve, failed >1, and failed ≥2 preventives was based on patient report of previous discontinuation of a migraine preventive due to lack of efficacy, suboptimal efficacy, or intolerability.16

See study design for EVOLVE-1 and EVOLVE-2

SELECT IMPORTANT SAFETY INFORMATION
Hypersensitivity Reactions

Hypersensitivity reactions (e.g., rash, urticaria, and dyspnea) have been reported with Emgality in clinical studies. If a serious or severe hypersensitivity reaction occurs, discontinue administration of Emgality and initiate appropriate therapy. Hypersensitivity reactions can occur days after administration and may be prolonged.

Indications and Important Safety Information
Indications

Emgality is a calcitonin gene-related peptide (CGRP) antagonist indicated for the preventive treatment of migraine in adults.

Important Safety Information

CONTRAINDICATIONS
Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.


WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions (e.g., rash, urticaria, and dyspnea) have been reported with Emgality in clinical studies. If a serious or severe hypersensitivity reaction occurs, discontinue administration of Emgality and initiate appropriate therapy. Hypersensitivity reactions can occur days after administration and may be prolonged.


ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in Emgality clinical studies were injection site reactions.


Emgality is available by prescription only.


Please see Full Prescribing Information, including Patient Information for Emgality. See Instructions for Use included with the pen and prefilled syringe.


GZ HCP ISI 27SEP2018